1. Field of the Invention
The present invention relates generally to belt-like articles of clothing, and more particularly to a stretchable and adjustable belt which holds a peritoneal dialysis catheter device stable against a user, thereby virtually preventing any trauma to an exit site from which the catheter device extends out of the user's body.
2. Description of the Related Art
Dialysis is a way of cleaning the blood when a person's kidneys can no longer perform their function. Not long ago, total kidney failure meant death. Today, there are almost 200,000 people with end-stage kidney disease in the United States alone. They are being kept alive because of treatments such as dialysis and kidney transplant. Dialysis substitutes for the kidneys by removing the body's wastes, which include excess salt and water. Dialysis also helps control blood pressure. Two basic methods of dialysis exist: hemodialysis and peritoneal dialysis. In the hemodialysis method, blood is pumped out of the body to an artificial kidney machine which contains a special membrane to filter the blood and remove wastes. The cleansed blood is then returned to the body by tubes that connect the patient to the machine. The hemodialysis procedure takes approximately four hours and must be performed three times a week. Although hemodialysis is effective at removing wastes from the blood, patients are traumatized by the procedure. They often feel exhausted for a day or more afterwards, at which point it's time to repeat the procedure.
Peritoneal dialysis is the other method of dialysis. In this method, the wastes are filtered out of the blood across a lining of the patient's abdominal cavity. The lining is called the peritoneum and serves as a natural filtering membrane. In peritoneal dialysis, wastes are removed by means of a sterile cleansing fluid which is washed in and out of the abdomen in cycles. A soft plastic tube called a catheter is surgically placed in the patient's lower abdomen. The cleansing fluid enters the abdomen through the catheter. Wastes from the blood pass through the peritoneal membrane into the cleansing fluid. Later, when the filtering process is completed, the fluid leaves the body through the catheter.
Another name for peritoneal dialysis is "Continuous Ambulatory Peritoneal Dialysis" (CAPD). The process of CAPD does not require the patient to use a dialysis machine, and may be performed at home, at the work place or anywhere where a calm and semi-sterile environment can be temporarily established. Out of the 600,000 patients worldwide who are being treated with dialysis, a significant number, approximately 100,000, use CAPD. Patients can personally perform the procedure by placing approximately two liters of cleansing fluid in their abdominal cavity and later draining it. The procedure begins by attaching a solution container and a drain bag (two flexible plastic bags) to the catheter in the patient's abdomen through a connecting length of tubing. Raising the solution container to shoulder level causes the force of gravity to pull the solution into the abdominal cavity. While the person goes about everyday activities, wastes and excess water pass from the patient's blood stream through the network of tiny blood vessels in the peritoneal membrane and into the solution. When the CAPD is completed, an empty plastic drain bag is lowered to a surface below the abdomen. Then the solution, which now contains wastes, drains by gravity from the abdominal cavity back into the bag. The used containers are then thrown away. This process usually is performed four times during any 24-hour period while the patient is awake. Each exchange takes about 30 minutes to complete.
Compared to hemodialysis, CAPD offers several advantages. With the continuous dialysis, the patient does not have large fluid gains which may reduce stress on the heart and blood vessels. Fewer dietary restrictions are required and a need for certain medications is decreased. No long interruptions in daily activities occur and patients find work and travel arrangements much easier to perform. However, there are some difficulties with peritoneal dialysis. For example, patients on peritoneal dialysis are constantly inconvenienced by the long plastic tube, generally about two feet in length, exiting from their lower abdomen. The exit site in the abdomen is easily irritated by the tube being tugged and moved as the person moves. These injuries occur daily and cause problems ranging from simple pain and discomfort to severe infections and peritonitis. If not treated promptly peritonitis can lead to death.
The problem area is in supporting the catheter tubing. Unfortunately, to date, there has been no satisfactory way to support this tube that has been commercially available. Tape is a good temporary solution but, over time, tends to really irritate the skin. Some patients have even required medical treatment because skin breakdown was so severe. Burnnet (Systenet.TM.) is used on many users who cannot tolerate tape but that also can be uncomfortable and expensive for long-term use.
When a catheter is poorly supported it becomes a nuisance and an annoyance. More importantly, when a catheter is dangling it is more prone to traumatic injury. This can lead to exit site complications and infection which may require medical intervention. In extreme cases the trauma has caused the need for catheter replacement, a full fledged surgical procedure.
In an attempt to overcome these difficulties mentioned above, and to help eliminate serious medical risk, inventors have tried to design devices to restrain the tubing from movement. Kaplan U.S. Pat. No. 4,096,863 discloses a band and various straps for anchoring a catheter to the body. Unfortunately, Kaplan's device is unnecessarily complicated, and is cumbersome to wear under street clothing. In addition, a rigid clip applied to the belt-like device interferes with comfort, restful sleeping and needlessly adds additional time to each 30 minute dialysis procedure. In each procedure, the Kaplan device must be totally unfastened before the catheter transfer set valve can be used. Kovacs, in U.S. Pat. No.4,445,894 illustrates a band strapped to the body utilizing two opposing Velcro TM.TM.-like fasteners to restrain the catheter. While Kovacs has devised a simpler solution to Kaplan's method, it is not optimized because the catheter easily slides back and forth when used for peritoneal dialysis, causing trauma to the exit site. Endo's U.S. Pat. No. 4,955,867 teaches a belt-like device incorporating a pouch to hold the valve end of the catheter. However, serious trauma to the exit site results because the approximately two foot length of tubing remains unsecured. Therefore, the dangling tubing is tugged and moved by the wearer, stressing the exit site. Furthermore, the pouch is fastened on top of the belt material making Endo's device unnecessarily thick. To applicants' knowledge, the Endo device product has not been produced and is not commercially available, presumably because of the aforementioned problems. Finally, U.S. Pat. Nos. 4,976,700 and 5,098,399 teach a catheter and tubing immobilizer. However, this invention is inadequate for several reasons. While it immobilizes the tubing at the exit site, it leaves the valve end dangling and unprotected. It is for one-time use only, must be disposed of after use, and causes irritation and allergic reaction on the user's skin because of the adhesive tape backing that is used to secure the device to the skin.
Therefore, with all the above noted problems, there; is still an urgent and continuing need for an improved apparatus and method to stabilize a peritoneal dialysis catheter, without causing trauma to the user at the exit site.